Sim&Size

Software For Visualization Of Vascular Anatomy And Intravascular Devices

Sim&Cure

The following data is part of a premarket notification filed by Sim&cure with the FDA for Sim&size.

Pre-market Notification Details

Device IDK202322
510k NumberK202322
Device Name:Sim&Size
ClassificationSoftware For Visualization Of Vascular Anatomy And Intravascular Devices
Applicant Sim&Cure 95 Rue Pierre Flourens Batiment H Montpellier,  FR 34090
ContactCaroline Oziel
CorrespondentCaroline Oziel
Sim&Cure 95 Rue Pierre Flourens Batiment H Montpellier,  FR 34090
Product CodePZO  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-17
Decision Date2020-12-31

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.